The “on-sale bar” deems that certain sales of an invention that occur more than one year before a patent application is filed are a bar to patentability. See 35 U.S.C. § 102(b) (pre-America Invents Act (“AIA”)); 35 U.S.C. § 102(a)(1) (AIA). On Monday, June 25, 2018, the Supreme Court granted Helsinn’s petition for certiorari in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., to interpret the on-sale bar provision of 35 U.S.C. § 102 in the AIA. Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., — S. Ct. —, 2018 WL 1142984 (2018) [SCOTUSblog case file]. The question presented to the Supreme Court is: “Whether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.” Petition for Certiorari, Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., No. 17-1229, 2018 WL 1168243 (Feb. 28, 2018).
Teva attempted to invalidate Helsinn’s patents to injectable low-dose palonosetron anti-nausea treatments under both pre- and post-AIA § 102 (Helsinn had patents filed both before and after the AIA implementation date). Helsinn Healthcare S.A. v. Dr. Reddy’s Labs. Ltd., No. 11-3692, 2016 WL 832089 (D.N.J. Mar. 3, 2016). Before the patents’ critical date, Helsinn entered into a license agreement and a supply and purchase agreement with MGI Pharma, which included an option to produce the patented product. Id. at *5, *27. Most of the terms of the agreement were publicly disclosed, but the price terms and specific dosages subject to the license (including the patented dose) were kept confidential and subject to confidentiality provisions. Id. at *29. The District Court found that the agreement was a commercial offer for sale under pre-AIA § 102 (though it did not invalidate the pre-AIA claims because the invention was not ready for patenting before the critical date), but was not a sale under post-AIA § 102 because the patented dosage had not been publicly disclosed. Id. at *45, *49–64.
The Federal Circuit reversed, holding that post-AIA § 102 did not change the statutory meaning of “on sale” to automatically exclude secret or confidential sales and offers for sale. Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., 855 F.3d 1356, 1360, 1370–71 (Fed. Cir. 2017). The panel rejected Helsinn’s legislative history arguments and held that in this situation, it was enough that the agreement itself was publicly disclosed—the specific details of the claimed invention did not need to be disclosed. Id. at 1368–71. The Federal Circuit disagreed with the District Court and held that, for both the pre-AIA and AIA bars, the invention was ready for patenting by the critical date. Id. at 1371–75. Helsinn petitioned for rehearing en banc, but the Federal Circuit denied Helsinn’s request. Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., No. 2016–1284, 2016–1787, 2018 WL 1583031 (Fed. Cir. Jan. 16, 2018).
Helsinn then petitioned for certiorari, seeking review of the Federal Circuit’s interpretation of the on-sale bar in the AIA context. Helsinn reiterated its argument that the words “or otherwise available to the public,” added to AIA § 102(a)(1), modified the on-sale bar to require sales to publicly disclose the claimed invention, not just the existence of an agreement. See, e.g., Petition for Certiorari, 2018 WL 1168243, at *4, *15–18. Helsinn also argued that the legislative history and PTO interpretations accord with its interpretation of the statute. Id. at *7–8, *11, *20–21, *27–28. Will the Supreme Court agree? Stay tuned.